Cleared Traditional

PROGRAMMABLE SPINAL CORAL STIM. SYSTEM (K810182) - FDA 510(k) Clearance

Class II Neurology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K810182 · Electronic Diagnostics, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1981
Decision
71d
Days
Class 2
Risk

K810182 is an FDA 510(k) clearance for the PROGRAMMABLE SPINAL CORAL STIM. SYSTEM. Classified as Stimulator, Spinal-cord, Implanted (pain Relief) (product code GZB), Class II - Special Controls.

Submitted by Electronic Diagnostics, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 3, 1981 after a review of 71 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5880 - the FDA neurology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Electronic Diagnostics, Inc. devices

Submission Details

510(k) Number K810182 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 22, 1981
Decision Date April 03, 1981
Days to Decision 71 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
77d faster than avg
Panel avg: 148d · This submission: 71d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GZB Stimulator, Spinal-cord, Implanted (pain Relief)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5880
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.

Regulatory Peers - GZB Stimulator, Spinal-cord, Implanted (pain Relief)

All 71
Devices cleared under the same product code (GZB) and FDA review panel - the closest regulatory comparables to K810182.
MEDTRONIC DUAL CHANNEL SPINAL CORD STIM
K812155 · Medtronic Vascular · Oct 1981
MEDTRONIC #3484 PISCES EPIDURAL LEAD
K812154 · Medtronic Vascular · Aug 1981
MYELOSTAT DORSAL CORD STIMULATOR
K811655 · Medtronic Vascular · Jul 1981
CORDIS STIMUCORD EXTERNAL NEUTRAL STIM
K810319 · Cordis Corp. · Feb 1981
MYELOSTAT DORSAL CORD STIMULATOR, ETC.
K801384 · Medtronic Vascular · Jul 1980
MEDTRONIC PISCES GENERATION II LEAD KIT
K800193 · Medtronic Vascular · Feb 1980